Lead Formulation Technician - First Rotating

JOB DESCRIPTION

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided

Job Description

Summary

Operates equipment used to manufacture products. Weighs, measures and checks raw materials to ensure that batches manufactured conta i n prope r ingredients in proper quantities. (Serves as SME) Acts as a SME (techn i cal expertise) and demonstrates mastery of tasks and processes in manufacturing drug product injectab l es in a cleanroom environment and fo l lowing GMP standards . Conduct quality investigations and support process optim i zations . Autonomously run equipment , pumps , and a u tomated systems and train team members to ensure it's right the first t i me and on sc h edule . Push fluids through filters in chromatog r aphy co l umns . Set flow paths for the operations , fo l l owing SOPs and Batch records and recommend i ng improvements.

Responsibilities

• Acts as a Lead technician on the floor providing gu i dance to other technicians and driv i ng daily operations . Provide critica l eva l uation of processes, i nc l uding foresight and thinking ahead. Act as a guide to new employees during onboarding process. Has substantial understanding of the job and applies knowledge and skil l s to comp l ete a wide r ange of tasks.

• High Leve l Ski l led: Aseptic Gowning I material flow, Applicable processing equipment , SAP/BLV. Works on assignments that are mode r ate l y difficult, requir i ng judgment in r esolving issues or in making recommendations.

• High impact to work. Performs all duties in strict compl i ance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines . Maintains the necessary compliance status required by company and facility s t andards .

• Stays up to date on required job training. Maintains up to date training records. Qualified trainer on all complex equipment/processes. Completed QT-SME curricula, Support training revisions, and new equipment development.

• SME or Expert on >3 Unit Operations . Obtains samples of batches/products i n accordance with company procedures; submits samp l es to required functional areas fo r t es t ing and to determine specific properties . Records/analyzes results and t akes appropriate action.

• Responsible for the upkeep of manufacturing equipment. Recognizes equipment and product problems, notifies supervisor and/or troub l eshoots errors in order to achieve optimum production l eve l s. Assist repair efforts, to increase understanding of equipment below the surface.

• Review, revise, & author manufacturing batch records. Co ll aborate with Quality & PD to rev i ew & signoff on executed batch records . Own the batch record reconciliation . Review , revise , & Author Wls/SOPs . Participate in lot disposition meetings and addresses client comments as needed.

• Adhere to the Quality Management Systems by l i ving the Quality values every day and holds peers across the site accountable as well. Assist with t he on-time closure of Nonconfo r mance ' s/ CAPAs. Assists in QUIC submission, and triage as needed.

• Lead PPI/JDI initiatives and continuous improvements. Encourages peers to think outside the box, coaching team to make documented improvements to process, maintaining attribution during idea flow to make team shine.

• Identify and communicate items requiring escalation; execute post esca l ation decisions. Provide frequent feedback and coaching to others on ways to improve performance . Receives and checks raw mater i als and formulation deliveries and completes appropriate records in accordance with company procedu r es (MFP's/EOP's/LOP's/SOP's).

• Active participant of performance huddles and assist supervisors to plan out and populate process schedules, including break timing.

• Maintain a cu l ture of safety by identification of near misses , safety walkthroughs and assisting with resolution of safety observations . Ensure chemicals are properly stored and la be l ed . Leads daily safety chats with team to identify relevant hazards of process.

• 90% of time spent on the floor
• Work Hours:
  • This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays.

• Education/Experience/Equivalency:
  • High School Diploma/ 4+ years of relevant experience or superior demonstration of skill sets or background

• Knowledge, Skills and Abilities: Full GMP understanding . Demonstrated ability to l ead and mentor. Understanding of the sc i ence beh i nd the proc e ss with abil i ty int erpret data and inputs . Strong communicat i on skills (verbal and written). Good autonomous p rob l em­ solving ski l ls . Investigative skills. Understand cleanroom concepts. Ab ili ty to follow di r ect i ons & procedures and work in team environment. Strong atten ti on to detail and dr i ve to accomplish the job time l y , a c curately, and safely t he first time is required , as well as the abil i ty to work c l ose ly and effectively in a team environment. This p o s i tion w i ll generally require the ability to work a 12- hour rotating shift in a 24-hour, 7 day per week operation to include eveni n gs and holidays. Ability to app ly knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes , equipment, instrumentation , and procedures. Adhere t o al l Personal Protective Equipment (PPE) requirements used with in cGMP manufacturing.
• Physical Requirements: Employee is regularly requi r ed to stand ; use hands to finge r , handle , or feel ; re ach w ith hands and arms ; s i t and to ta l k or hear. The employee is required to walk and stoop , or kneel , crouch approximate l y 80% of the time . The emp l oyee is required to ascend/ descend sta ir s approximately 20% of the time , l ift a maximum of 50 lbs ., and sit for a maximum of 4 hours. Spec ifi c vis i on abilit i es required by th i s j ob include c l ose visi o n and abi lit y to adjust focus with tasks.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, lnvitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit

Compensation and Benefits

The hourly pay range estimated for this position based in Massachusetts is $26.98–$40.47.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: